|
|
| Device Name |
Company |
Date Approved |
Supplement Reason |
Other Information |
|
Dexcom, Inc. |
Jan 22, 2015 |
process change - manufacturer/sterilizer/packager/supplier
|
|
|
Dexcom, Inc. |
Aug 19, 2015 |
change design/components/specifications/material
|
|
|
Dexcom, Inc. |
Apr 16, 2015 |
process change - manufacturer/sterilizer/packager/supplier
|
|
|
Dexcom, Inc. |
Jun 03, 2015 |
process change - manufacturer/sterilizer/packager/supplier
|
|
|
Dexcom, Inc. |
Jul 02, 2015 |
change design/components/specifications/material
|
|
|
Dexcom, Inc. |
Sep 23, 2015 |
change design/components/specifications/material
|
|
|
Dexcom, Inc. |
Nov 06, 2015 |
process change - manufacturer/sterilizer/packager/supplier
|
|
|
Dexcom, Inc. |
Oct 23, 2015 |
process change - manufacturer/sterilizer/packager/supplier
|
|
|
Dexcom, Inc. |
Nov 25, 2015 |
process change - manufacturer/sterilizer/packager/supplier
|
|
|
Dexcom, Inc. |
Dec 20, 2016 |
change design/components/specifications/material
|
Approval Order Summary of Safety & Effectiveness Labeling
|